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Editorial: More on the United States Pharmacopeia General Notices, Part IV

Section 3 of the United States Pharmacopeia (USP) General Notices discusses Conformance to Standards and is divided into the following areas:

The standards are described in the Monographs, applicable General Chapters, and General Notices. Any exemptions to the standards may be expressed elsewhere in the compendium. When revised standards are issued, early adoption is allowed. Revised standards become official six months after publication as final approved "official text." The standards apply at all times in the life of the article from production to expiration. The standards apply to any article marketed in the U.S. that is either recognized in the compendium and is labeled or intended for use as a drug or as an ingredient in a drug. The standards apply both to articles with the official titles as well as to names derived by moving around the definitive words of official titles or transposition in the order of the names of two or more active ingredients in official titles; also the standards apply where synonyms are used with the intent or effect of suggesting a significant degree of identity with the official title or name.

When can the designation "USP" or "National Formulary (NF)" be used? It can be used with the official title or on the label only when a monograph is provided in the specified compendium and the article complies with the identity prescribed. When an article differs from the USP or NF standard of strength, quality, or purity set forth in the relevant compendium, its difference is to be stated on the label. If the drug product, substance or excipient does not comply with the identity standards in the USP or NF, or contains an added substance that interferes with the tests and procedures, it shall be given a name that is clearly different from any name recognized in the USP or NF.

The use of the designation USP or NF on the label does not constitute an endorsement by The United States Pharmacopeia, Inc. (USP) nor does it represent assurance by USP that the article is known to comply with relevant standards.

Next week we will look at Section 4. Monographs and General Chapters.


Loyd V. Allen, Jr., Ph.D., R.Ph.
Editor-in-Chief

J&J's Doxil Woes Show Shortages Aren't Easily Fixed
The Doxil supply problems stem from outsourced manufacturing. The contract manufacturing organization (CMO) producing it decided to get out of contract work, Reuters reports, amid problems with one of its plants, leaving J&J with a shortage. J&J has been working with a new manufacturer and, in the meantime, its current CMO is trying to increase production long enough to get a limited supply onto the market within six weeks. Even with this, that batch probably won't be enough to treat all the patients on a waiting list, J&J says. J&J expects the drug to remain in short supply until completion of the move to the new manufacturer.

Doxil is only one of many key cancer drugs in short supply at a time when the number of drug shortages has risen to record levels. This is requiring both hospitals and pharmacies to become drug-supply detectives, spending time and resources tracking down scarce products. Now, gray-market suppliers have stepped into the breach with wildly inflated prices and questionable practices.
http://www.reuters.com/article/2011/09/27/johnsonjohnson-idUSL3E7KR0EO20110927

NIOSH Seeking Comments on Hazardous Drugs List
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) is requesting comment on some proposed additions and deletions to the current list of hazardous drugs. NIOSH reviewed the comments to date and revised the proposed list to 31 additions, 4 reclassifications, and 11 deletions. One can go to the website listed below to review the proposed changes. Comments will be accepted until 5:00 p.m. EDT on October 3, 2011. Visit the website for detailed instructions on how to participate.
http://www.cdc.gov/niosh/docket/review/docket190/default.html

Drug Disposal National Take-back Day Scheduled
The DEA has scheduled another National Prescription Drug Take-back Day on Saturday, October 29, 2011, from 10:00 am to 2:00 pm to provide a procedure for individuals to dispose of unwanted and unused prescription drugs.

The DEA, in conjunction with state and local law enforcement agencies throughout the U.S., conducted National Prescription Drug Take-back Days on Saturday, September 25, 2010 and April 25, 2011. Nearly 4,000 state and local law enforcement agencies throughout the nation participated in these events, collecting more than 309 tons of medications.

Four days after last fall's Take-back Day, Congress passed legislation amending the Controlled Substances Act to allow the DEA to develop a process for people to safely dispose of their prescription drugs. DEA immediately began developing this process after the President signed the Safe and Secure Drug Disposal Act of 2010 on October 12. Until that process is complete, however, DEA will continue to hold Take-back Days every six months.
http://www.deadiversion.usdoj.gov/drug_disposal/takeback/index.html

Physicochemical Principles of Pharmacy, 5th ed.
Florence AT, Attwood D
September 2011
Paperback; 528 pages; $65.00

The basis for pharmaceutical compounding, formulation, and processing is an understanding of physicochemical principles. These principles not only affect the physical, chemical, and microbiological stability of the drug formulation, but also drug delivery and absorption.

This new edition is divided into 13 chapters; (1) Solids, (2) Physicochemical properties of drugs in solution, (3) Drug stability, (4) The solubility of drugs, (5) Surfactants, (6) Emulsions, suspensions and other disperse systems, (7) Polymers and macromolecules, (8) Pharmaceutical nanotechnology, (9) Drug absorption and the oral route, (10) Parenteral routes of drug administration, (11) Physicochemical drug interactions and incompatibilities, (12) Peptides, proteins and other biopharmaceuticals, and (13) Physical assessment of dosage forms.

Changes in this edition include the new chapter on pharmaceutical nanotechnology, key learning points, more complete examples of clinical calculations, and a more clear distinction between the basic text and more complex theory. This recommended book is easy-to-read and is an asset to compounding and formulation pharmacists.

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